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AMIKACIN RMB amikacin (as sulfate) 500 mg/2mL solution for injection ampoule - TGA Drug Approval Details
Approvals
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TGA
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AMIKACIN RMB amikacin (as sulfate) 500 mg/2mL solution for injection ampoule
Approved
STANDARD
AMIKACIN RMB amikacin (as sulfate) 500 mg/2mL solution for injection ampoule
Southern XP IP Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
1135d2ea621d463d
Company
Southern XP IP Pty Ltd
Type
Standard
Approval Details
Approval Id
1135d2ea621d463d
Product Name
AMIKACIN RMB amikacin (as sulfate) 500 mg/2mL solution for injection ampoule
Artg Id
262735
Artg Name
AMIKACIN RMB amikacin (as sulfate) 500 mg/2mL solution for injection ampoule
Sponsor
Southern XP IP Pty Ltd
Company Detail Path
/organization/southern-xp-ip-pty-ltd
Artg Date
2017-02-07
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
1135d2ea621d463d
Type
Standard
Back to TGA Approvals